Peritoneal CarcinomatosisPhase 2NCT04779554
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC
A Phase 2 study testing Mitomycin C, flat dose 40 mg and Mitomycin C, weight-based dose 12.5 mg/m2 in people with Peritoneal Carcinomatosis, run by Prakash Pandalai at 2 sites in United States.
Trial summary
Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- Mitomycin C, flat dose 40 mg and Mitomycin C, weight-based dose 12.5 mg/m2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2021to Feb 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis
- ECOG performance status < 3
- Candidate for grossly complete cytoreductive surgery
- Life expectancy greater than 3 months
- Adequate organ and marrow function
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Any extra-abdominal metastases
- Untreated lung metastases
- Liver metastases not amenable to resection or ablation
- Known brain metastases
- Chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Presence of residual significant adverse events attributed to prior cancer treatment
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- Currently receiving any other investigational therapeutic agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.
- Pregnant or breast-feeding women
- Uncontrolled ongoing illness
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Jessica Cintolo-Gonzalez, 802-847-2262, jessica.cintolo-gonzalez@uvmhealth.org
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Prakash Pandalai, MD, Prakash.Pandalai@uky.edu
About this study
Official title: A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy
Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected peritoneal surfaces, has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited. Additionally, hyperthermia is known to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth of peritoneal penetration.
This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity, compared with the HIPEC flat dosing approach in patients undergoing CRS/HIPEC.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- Mitomycin C, flat dose 40 mg, Mitomycin C, weight-based dose 12.5 mg/m2
- Keywords
- cytoreductive surgery, colorectal cancer, pseudomyxoma peritonei, appendiceal mucinous neoplasm, mitomycin C, pharmacokinetics, CRS/HIPEC, HIPEC, Appendix cancer, LAMN
- Medical subject headings
- Peritoneal Neoplasms, Colorectal Neoplasms, Pseudomyxoma Peritonei, Appendiceal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin C, flat dose 40 mgDrug
Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two flat doses. Dose 1 will be 30mg at minute 0 and dose 2 will be 10 mg at minute 45.
Mitomycin C, weight-based dose 12.5 mg/m2Drug
Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two weight-based doses of 9.5 mg/m2 at minute 0 and 3 mg/m2 at minute 45.
| Study group | Role | What they receive |
|---|---|---|
| Flat Dose Mitomycin C | Experimental | Participants in this group will receive flat doses of mitomycin C intra-operatively: 1) 30mg at minute 0 and 2) 10mg at minute 45. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy). Receives: Drug: Mitomycin C, flat dose 40 mg |
| Weight-Based Mitomycin C | Experimental | Participants in this group will receive weight-based dosing of mitomycin C intra-operatively: 1) 9.5 mg/m2 at minute 0 and 2) 3 mg/m2 at minute 45 for total dose of 12.5 mg/m2. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy). Receives: Drug: Mitomycin C, weight-based dose 12.5 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) - Pharmacokinetics
Drug exposure will be measured by calculating the area under the curve (AUC) or integral of a plasma concentration-time curve. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.
Measured: Approximately 20 hours
Drug Clearance (CL) - Pharmacokinetics
Drug clearance will be calculated as the volume of plasma cleared per unit time. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.
Measured: Approximately 20 hours
Drug Half-Life (T1/2) - Pharmacokinetics
Drug half-life will be calculated as the time required for the plasma Mitomycin C concentration to be half of its maximum concentration. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.
Measured: Approximately 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start4 Jun 2021
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prakash Pandalai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prakash Pandalai, University of Kentucky
- Investigators
- Prakash Pandalai, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779554
- Sponsor's protocol ID
- MCC-20-GI-115
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.
PubMed 36410913